NCT04085991

Brief Summary

Single-arm, open-label, phase II trial in 200 competent adult male patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-3 and progressive metastatic prostate cancer, failing, failed, refused, not eligible for or no access to further approved lines of therapy. Patients will undergo sequential FDG positron emission tomography (PET) and 18F-DCFPyL PET to assess FDG/DCFPyL concordance fraction. Patients with DCFPyL/FDG concordance of 50% or greater will be treated with 131I-PSMA-1095 radioligand therapy (RLT). Best post-treatment serum prostate specific antigen response will be compared to concordance fraction.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

July 31, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

2.5 years

First QC Date

September 8, 2019

Last Update Submit

April 10, 2023

Conditions

Prostate CancerProstate AdenocarcinomaProstatic NeoplasmsMetastatic Prostate CancerMetastatic Prostatic AdenocarcinomaMetastatic Prostate Carcinoma in the Soft Tissue

Keywords

Radioligand therapyPSMAPSMA therapy1095

Outcome Measures

Primary Outcomes (1)

  • Serum prostate specific antigen (PSA)

    The best serum prostate specific antigen (PSA) response will be calculated for each patient as: pre-treatment PSA minus lowest post-treatment PSA divided by pre-treatment PSA. Best PSA response will be reported as percent reduction (or increase) from baseline.

    3 months post last dose of RLT

Secondary Outcomes (1)

  • Adverse events

    3 months post last dose of RLT

Study Arms (1)

131I-PSMA-1095 Radioligand Therapy (RLT)

EXPERIMENTAL

Intravenous injection of 100 mCi of 131I-PSMA-1095 RLT, Q8 weeks up to a maximum of 4 doses

Drug: 131I-PSMA-1095 Radioligand Therapy (RLT)

Interventions

131I-PSMA-1095 Radioligand Therapy (RLT)DRUG

Intravenous injection of 100 mCi of 131I-PSMA-1095, Q8 weeks up to a maximum of 4 doses.

Also known as: PSMA RLT
131I-PSMA-1095 Radioligand Therapy (RLT)

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale only.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Age 18 years or older
  • Documented metastatic adenocarcinoma of the prostate
  • Under active medical oncology care
  • ECOG performance status 0 - 3, inclusive
  • Able to understand and provide written informed consent
  • Able to tolerate the physical requirements of two PET/CT scans including lying for up to 30 minutes
  • Progressive disease on any of: bone scan, CT, MRI or serum PSA as judged by the investigator
  • Serum prostate specific antigen ≥ 1 ng/ml at baseline or CT/MRI soft-tissue measurable disease as per RECIST v1.1
  • Failed, failing, refused, no access to or not eligible for any approved prostate cancer therapies including but not limited to: ADT, NAAD (e.g., abiraterone, enzalutamide, darolutamide or apalutamide), docetaxel, cabazitaxel, radium-223 and oligometastatic RTX
  • Life expectancy of at least 3 months as judged by the investigator

You may not qualify if:

  • Medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
  • Exceeding the weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (approximately 70 cm diameter)
  • Unmanageable claustrophobia
  • Prior failure of PSMA RLT
  • Prior hemi-body irradiation
  • Impaired organ function as evidenced by any of the following laboratory values:
  • Absolute neutrophil count \< 1.5 x109/L
  • Platelet count \< 75 x109/L
  • Hemoglobin \< 85 g/L
  • Albumin \< 2.5 g/dL (25 g/L)
  • Total bilirubin \> 2 x ULN (unless in instances of Gilbert's disease)
  • AST or ALT \> 2.5 x ULN (or \> 5.0 x ULN in the presence of liver metastases)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stephan Probst

Montreal, Quebec, H3T1E2, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Stephan Probst, MD

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Nuclear Medicine

Study Record Dates

First Submitted

September 8, 2019

First Posted

September 11, 2019

Study Start

July 31, 2020

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)